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Search / Trial NCT06081439

Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

Launched by VASTRA GOTALAND REGION · Oct 6, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying mental fatigue in patients with Graves' disease, a condition where the thyroid gland is overactive. Researchers believe that even after thyroid hormone levels return to normal, some patients may still experience mental fatigue due to autoimmune factors. To explore this, the trial will assess 310 patients for various symptoms, including mental fatigue, quality of life, anxiety, and stress, both shortly after being diagnosed and again after about 15 months of treatment. They will also look at blood and spinal fluid samples to identify possible markers that could be linked to this fatigue.

Eligible participants are adults aged between 18 and 75 who have recently been diagnosed with Graves' disease and have specific thyroid-related antibodies. Those who cannot follow the study protocol, such as individuals with severe mental health issues or other significant health conditions, will not be included. Participants can expect to undergo several assessments, including questionnaires about their symptoms and brain scans to understand how their brain functions during tasks. This research aims to uncover the underlying causes of mental fatigue in Graves' disease and help improve the quality of life for patients experiencing these symptoms.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Recently diagnosed Graves' disease
  • Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb)
  • Thyroid hormones above the upper reference limit
  • Inclusion within three weeks after start of antithyroid drugs
  • Controls: Matched for gender and age
  • Exclusion Criteria:
  • Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
  • Recidive of Graves' disease
  • Pregnancy
  • Controls: -Thyroid disease
  • Neurological disease

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Gothenburg, , Sweden

Patients applied

0 patients applied

Trial Officials

Helena Filipsson, ass prof

Principal Investigator

Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Department of Endocrinology, Sahlgrenska University Hospital, Wallenberg Center for Molecular and Translational Medicine, all in Gothenburg, Sweden

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported